Use COTA data and research expertise to design effective studies and support your treatment’s regulatory submissions.
In addition to high-quality, cancer-specific data, COTA offers support services to help you design your trials, control arms, or comparator arms in the most effective way possible.
COTA’s cancer-specific data, compliant with 21 CFR Part 11, helps regulatory teams:
COTA’s expertise in research design, analysis and high-quality data have been used to support successful submissions to both the FDA and EMA.
*Depending on diagnosis
Focus is perfect for regulatory teams looking to support their regulatory submissions for a specific cancer treatment. Focus provides regulatory-grade patient data that is curated for your specific use case and can be used to supplement clinical trial data and construct ECAs.
Real-World Insights and Support is an optional, complementary add-on service that adds personalized expertise and support to your data. Our clinical and statistical experts work either as clinical advisors or as the execution arm of your team (depending on the data you choose), to provide statistical analysis and streamline study designs.
Contact COTA to learn more about solutions for cancer regulatory teams.
